Home IV fluid infusions after radical cystectomy
Official title: Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial
Run by Johns Hopkins University · NCT07225205 · Data updated 2026-11-12
This trial will test whether giving home IV fluids after radical cystectomy for bladder cancer reduces 90-day hospital readmissions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | February 1, 2028 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07225205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with confirmed urothelial carcinoma who choose to undergo radical cystectomy and have no contraindication to home IV therapy are ideal candidates.
✕Probably not a fit
Patients with cardiac, renal, or hepatic dysfunction, those requiring pelvic exenteration, or those unable/unwilling to complete follow-up or receive home infusions are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Johns Hopkins is conducting a single-center randomized controlled trial in adults undergoing radical cystectomy for urothelial bladder cancer. Patients are randomized to an Enhanced Recovery After Surgery (ERAS) pathway with a home intravenous fluid program (1 L crystalloid three times per week for four weeks) or ERAS alone. The primary outcome is 90-day hospital readmission, with secondary outcomes including 30- and 90-day complications. Patients with contraindications to home IV therapy or those needing more extensive pelvic exenteration are excluded.
Why it matters
Potential benefit: If successful, adding a home IV program could reduce dehydration-related complications and lower 90-day readmission rates after radical cystectomy.
How similar studies have gone: A prior prospective study suggested a substantial decrease in 90-day readmissions with a home IVF program, but high-quality randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients greater than 18 years of age and older * Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology * Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist. Exclusion Criteria: * Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms) * Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers). * Patients with extensive locally advanced disease necessitating a pelvic exenteration * Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction) * Unwilling or unable to participate in 30 and 90 day follow-up phone calls.
Where it's running
-
Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting -
Johns Hopkins Hospital
Baltimore, Maryland, United States Not yet recruiting
Study contacts
- Principal investigator: Max Kates, MD — Johns Hopkins School of Medicine
- Study coordinator: Tyler S Garman, MD
- Email: tgarman1@jhu.edu
- Phone: 410-955-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.